Cleared Traditional

NGM NIBP MODULE

K911645 · Datex Division Instrumentarium Corp. · Cardiovascular
Mar 1992
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K911645 is an FDA 510(k) clearance for the NGM NIBP MODULE, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Datex Division Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on March 4, 1992, 324 days after receiving the submission on April 15, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K911645 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1991
Decision Date March 04, 1992
Days to Decision 324 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DXN — System, Measurement, Blood-pressure, Non-invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1130

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